Changing a published GUDID record: field edits versus new-DI triggers
Treat an edit permission and a new-DI trigger as separate columns. The FDA reference marks brand name and model/version as new-DI triggers with no ordinary post-grace-period edits, while catalog number and device description have different recorded edit rules. Its footnote also says ordinary edit rules do not describe an unlocked record. Scope the specific change before choosing an update or replacement workflow.
Evidence retrieved 2026-10-06. Source versions and topic-specific limits are listed below.
Observed FDA field relationships
Which fields change this workflow?
FDA Data Elements Reference Table; acquired link labelled December 17, 2024. Entry conditions and edit rules below are transcribed from that version.
A brand name is a trade/proprietary name assigned by the device labeler, and under which the device is sold, distinguished from other similar devices, and recognized by the user or purchaser. A brand name is often registered and/or protected by a trademark.
Recorded entry notes and format
Enter the brand name specific to this version/model of the device.
You may include the ® and/or TM symbol, if applicable. If there is no brand name for your device then enter NA or the name commonly used to refer to the device or family of devices. Information entered in this field should be greater than one character in length, and a name that refers to the device must be entered.
The version or model found on the device label or accompanying packaging used to identify a category or design of a device. The version or model identifies all devices that have specifications, performance, size, and composition within limits set by the labeler.
Recorded entry notes and format
Enter the Version or Model.
Version/Model can be any distinguishing string of letters and/or numbers.
If the device does not have a version or model, enter a concept that can be used to identify all devices that have specifications, performance, size, and composition within limits set by the labeler.
The catalog, reference, reorder or product number used by the labeler for business and clinical transactions to identify a particular product; this number may be found on the device label or labeling.
Recorded entry notes and format
The catalog number is critical for matching UDI to legacy device identification data used in the item masters, inventory systems, EHRs, and registries. The DI of the UDI will replace the catalog number for recalls and adverse event reports in the future.
To populate this field:
Use the catalog, reference, reorder or product number on the device label.
If there is no catalog, reference, reorder or product number use the number reported in a business/clinical transaction or that would be reported in case of a recall or adverse event.
Additional information about the device that is not already captured as a distinct GUDID data element.
Recorded entry notes and format
Device description should include any description found on the device label, package insert, or approved or cleared indications for use to support user identification. If you have multiple device records with similar information, this field should help users differentiate among the device records.
You may include URL links to: the label, instructions for use, device pictures/schematics. The inclusion of a URL is to supplement the description of the device. URLs can change over time. If a URL is included, please keep the URL up to date.
Duplicating information already provided as distinct data elements in GUDID, e.g. Brand name, company name, etc. is not necessary.
•Note: This field appears in the results summary from searches in AccessGUDID.
Data type: Type: Alphanum.
Length: 2000
Entry values: NA
Reference limits and edit-rule footnotes
Add = Addition of new data is allowed; Delete = Deletion of entered data is allowed; Edit = Editing of entered data is allowed; None = NO edit, add, or delete are allowed; NA = data element is not able to be changed directly; most are ‘auto-populated’ fields whose information depends on another data element
Note: The above do not apply if the device is “unlocked” for editing. For more information on “unlocking” device records for editing, please visit www.fda.gov/udi [5]
See 21 CFR 830.310 and 830.340 for required data elements. [6]
Most of the information presented here is applicable to GUDID HL7 SPL submissions, but there are some differences pertinent to each submission option. Please refer to the HL7 SPL Implementation package of files for additional details on HL7 SPL xml file submission option. [7]
These are dated FDA reference-table fields, not an automated legal applicability assessment or validated submission. The AccessGUDID download schema is different from the FDA HL7 SPL submission implementation package. No quarantined schema is used.
A mapping worksheet for this workflow
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Compare old and proposed controlled values
List exactly which brand, model, catalog and description fields are changing; reconcile label and device master-data changes.
Useful evidence: Before/after values, artwork and change-control rationale.
Review both reference columns
Compare each changed field’s edit rule and new-DI trigger. Confirm current FDA instructions and any unlock arrangement before submitting.
Useful evidence: A field-level change matrix and current record state.
Preserve the history
Prepare the previous/new record relationships and downstream impact plan if a new identifier is needed; do not overwrite the old mapping blindly.
Useful evidence: Identifier history, affected labels and downstream-system reconciliation.
Work packages and dependencies
Conditional: Changing a published GUDID record: field edits versus new-DI triggers — Review the controlled source evidence, prepare the field/relationship mapping described here, resolve exceptions and reconcile the intended records before confirming submission scope.
Questions for providers
Which changed fields trigger a new-DI assessment, and what evidence supports your decision?
Are you handling an ordinary published-record edit or a separately authorised unlock?
How are historical identifiers and downstream mappings retained?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
